Equipment

Application of single-use technology in a parenteral facility for syringe filling.

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

Both upstream and downstream processes can benefit from continuous manufacturing advantages.

Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

Consider these best practices when deciding to implement single-use components.

Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

After realizing benefits from the adoption of a single-use filling line for one specific product, Patheon took the leap and installed a single-use filling line in a new facility.

FDA updates guidance to reflect advances in technology.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

Shimadzu's LCMS-8040 combines newly improved ion optics and collision cell technology with proprietary ultrafast technologies.

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

Recycling is becoming a viable option for disposal of single-use systems.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2012 edition from EMD Millipore and Meissner Filtration Products.

Industry wants more innovation, but can suppliers meet customer needs?

Critical issues that should be considered when scaling up a hot-melt extrusion process.

Modular factory concepts, which take flexible manufacturing to the next level, are beginning to take hold in the biopharmaceutical industry.

On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

In a world where product recalls can mean the end of a company, all batches must be perfect.

Debottlenecking downstream mAb purification.

Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.

This column will address some of the questions on how single use systems are sterilized by gamma irradiation and what documentation may be requested by regulators.

New product reviews for January 2012.

Jerold Martin, senior vice president global technical affairs, at Pall Life Sciences, explains the importance and impact of single-use systems in sterile environments.

Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.

Biosimilar manufacturers need better expression systems and analytical tools to compete.